FDOPA-PET/MRI for the Pre-operative Evaluation of Gliomas

This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

St. Louis,
Missouri63110

Purpose:

This is a pilot study designed to evaluate the potential of using FDOPA-PET/MRI for
improving surgical planning and providing non-invasive prognostic information in patients
with gliomas that have substantial non-enhancing regions. The results will be used to
develop larger adequately powered studies.

Criteria:

Inclusion Criteria:
- Known or suspected diagnosis of intracranial glioma with substantial non-enhancing
regions as assessed by contrast enhanced MRI. For the purposes of this study, gliomas
with substantial non-enhancing regions are defined as having contrast-enhancing
volumes of less than 50% of the total estimated tumor volume. Gliomas that do not
have any contrast-enhancing regions are eligible for this study.
- Standard of care surgical resection and/or stereotactic biopsy of the brain tumor
planned within 2 weeks of the FDOPA-PET/MRI study.
- At least 18 years of age.
- Measurable disease on MRI defined as tumor measuring at least 1 cm in two
perpendicular dimensions.
- Karnofsky performance of > 50 corresponding to ECOG categories 0, 1, or 2. Patients
who are unable to walk because of paralysis, but who are up in a wheelchair, will be
considered ambulatory for the purpose of assessing the performance score.
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) > 30
mL/min/1.73 m^2
- Patient or legally authorized representative must be able to understand and willing
to sign a written informed consent document.
Exclusion Criteria:
- Patients undergoing PET/MRI: contraindication to gadolinium contrast enhanced brain
MRI (i.e., allergy to gadolinium contrast, MRI-incompatible implantable devices, GFR
< 30 mL/min/1.73, and severe claustrophobia). At the discretion of the responsible
physician, FDOPA-PET/CT may be performed if PET/MRI is contraindicated or
unavailable. If FDOPA-PET/CT is performed, the patient must have undergone a
contrast-enhanced MRI for fusion with FDOPA-PET no more than 4 weeks before the
FDOPA-PET/CT.
- Prior chemotherapy or radiation therapy for the brain tumor. Prior biopsy or surgical
resection of the glioma without additional therapy is not an exclusion criterion.
- Pregnant and/or breastfeeding. Women of childbearing potential must have a negative
urine or serum pregnancy test no more than 3 days prior to FDOPA injection.

NCT ID:

NCT02371031

Primary Contact:

Principal InvestigatorTammie Benzinger, M.D., Ph.D.Washington University School of Medicine

Backup Contact:

N/A

Location Contact:

St. Louis, Missouri 63110United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.